Senior Quality System Engineer (Hardware & Production) Salt Lake City

Sword Health is on a mission to free two billion people from pain. 

With 67% of members achieving a pain-free life and a 70% reduction in surgery intent, at Sword, we are using AI Care to change lives, and save millions for our 25,000+ enterprise clients across three continents. Today, we hold the majority of industry patents, win 70% of competitive evaluations, and have raised more than $300 million from top venture firms like Founders Fund, Sapphire Ventures, General Catalyst, and Khosla Ventures.

Recognized as a Forbes Best Startup Employer in 2025, this award highlights our focus on being a destination for the best and brightest  talent. Not only have we experienced unprecedented growth since our market debut in 2020,  but we’ve also created a remarkable mission and value-driven environment that is loved by our growing team. With a recent valuation of $3 billion, we are in a phase of hyper growth and expansion, and we’re looking for individuals with passion, commitment, and energy to help us scale our global impact. 

Joining Sword means committing to a set of core values, chief amongst them to “do it for the patients” every day, and to always “deliver more than expected” on behalf of our members and clients.

This is an opportunity for you to make a significant difference on a massive scale as you work alongside 900+ (and growing!) talented colleagues, spanning three continents. Your charge? To help us build a pain-free world, powered by AI, enhanced by people — accessible to all.

SUMMARY:

Sword Health is a health care company that provides AI care programs that tackle physical pain. Sword is committed to providing high-quality medical devices (SW and HW) that improve patient outcome and safety. As part of our ongoing commitment to excellence, we are seeking a talented and detail-oriented Senior Quality System Engineer (Hardware & Production).Reporting to the Expert Quality Engineer, as Senior Quality System Engineer (Hardware & Production), you will play a crucial role in ensuring the quality and regulatory compliance of the hardware components of medical devices and in ensuring quality throughout the production lines. You will collaborate with cross-functional teams, including research & systems, hardware development, supply chain, and production regulatory affairs, to uphold the highest standards of safety and effectiveness. The ideal candidate resides in the Salt Like City area.

Key Responsibilities :

Hardware Quality Assurance:

• Define and maintain QA strategies across the product lifecycle, with a focus on hardware development and integration into combination products.
• Provide quality support during product development and design changes, ensuring it complies with ISO 13485, FDA 21 CFR 820, IEC 60601
• Drive and support Design Transfer activities, ensuring appropriate controls are in place for scaling, qualification, and validation of equipment and processes
• Ensure proper traceability between design requirements, risk controls, and verification activities through DMR/Device Master Records.
• Conduct regular audits of production processes 

Process Improvement:

• Participate in validation lifecycle improvements, identifying process gaps in IQ/OQ/PQ documentation and long-term performance monitoring
• Support and develop process KPIs with R&S process development & improvement and QC/QA teams
• Leverage validation and production data to drive continuous improvement initiatives, using tools such as SPC, DOE, control charts, or capability studies.
• Contribute to change control assessments, ensuring that changes to hardware, test methods, or processes are evaluated for revalidation and risk impact.

Regulatory compliance:

• Translate regulatory requirements into practical, risk-based quality controls across design, validation, and manufacturing processes.
• Ensure validation activities are conducted and documented in accordance with regulatory expectations.

Supplier Management:

• Participate in the qualification and monitoring of critical suppliers.
• Support or lead supplier audits, and implement quality agreements that define validation responsibilities, traceability, and change notification processes.

Root Cause Analysis:

• Lead investigations into the applicable non-conformities, utilizing tools such as 5 Whys, Fishbone Diagrams, and Failure Modes and Effects Analysis (FMEA).
• Ensure non-conformity outputs are linked back to risk files, validation updates, and process improvements

Risk management:

• Collaborate with R&S, QARA, ISC and Tech Ops to maintain and update Product, Design and Process FMEAs
• Ensure risk control measures are implemented and verified during validation, and that any residual risks are documented and justified.

Documentation and Reporting:

• Own or contribute to the generation and maintenance of (audit-ready) documentation related to validation, qualification, and test method development
• Track and report quality metrics and KPIs, such as first-pass yield, rework rates, and validation deviations, to Quality leadership.

Hard Skills and expertise:

• Bachelor's degree in Science, Engineering or related discipline.
• 4–6 years of experience in Quality Assurance or Quality Engineering, preferably within medical device hardware development or manufacturing environments. 
• Solid understanding of core quality system processes, including: Document and Change Control; internal audits; design controls, CAPAs and non-conformities
• Demonstrated experience supporting new product development (NPD) and design transfer.
• Working knowledge of relevant medical device regulations and standards, including ISO 13485; 21 CFR Part 820; ISO 14971; ISO 60601
• Experience assisting in the execution of validation activities, such as protocol drafting, execution of IQ/OQ/PQ, data collection, and deviation handling.
• Familiarity with risk analysis tools, including FMEA (design/process), hazard analysis, and traceability matrices; ability to contribute to risk file maintenance.
• Comfortable using statistical tools for quality and validation (e.g., Excel, Minitab, Gage R&R, control charts); understanding of capability and trending metrics.
• Skilled in structured problem solving and root cause analysis techniques (5 Whys, Fishbone, Pareto); experience in documenting and following up on CAPAs.
• Six Sigma or Lean Manufacturing exposure is preferred; certification is a plus but not required. Focus is on practical experience.

Soft Skills and Attributes:

• Mission-first mindset – Understands that the ultimate goal is to serve patients, not just meet KPIs. Brings purpose to daily execution.
• Owner mentality – Takes full responsibility for assigned tasks, follows through independently, and contributes to team success. 
• Delivers more than expected – Goes beyond the minimum: prepares well, double-checks work, and delivers with accuracy under time pressure.
• Learns fast and adapts faster – Sees mistakes as opportunities to grow, asks for feedback, and adjusts quickly in a very fast-paced environment.
• Thrives in a high-performance environment – Knows how to manage shifting priorities, remains calm under pressure, and still uphold quality standards.
• Resourceful and efficient – Makes smart use of tools, templates, and support systems. Suggests better ways to work without being wasteful. 
• Collaborative communicator – Brings clarity and accountability in conversations with engineers, operations, suppliers, and QA leadership.